Mazdutide: China's Approved GLP-1/Glucagon Drug and Its US Status
Mazdutide is a once-weekly injection that activates both the GLP-1 and glucagon receptors, and it is approved in China (brand name Xinermei) for weight management and type 2 diabetes. It is not FDA approved. Eli Lilly, which invented it and holds the rights outside China, published a US Phase 2 trial in August 2026 but, in the sources we reviewed, has not announced a US Phase 3 obesity program.
Key takeaways
- China's NMPA approved mazdutide for chronic weight management in June 2025 and for type 2 diabetes glycemic control in September 2025, per Innovent.
- GLORY-1 (6 mg, 48 weeks) showed 14.8% average weight loss versus 0.5% on placebo; GLORY-2 (9 mg, 60 weeks) showed 18.55% versus 3.02%.
- In DREAMS-3, mazdutide 6 mg beat semaglutide 1 mg on the combined goal of HbA1c under 7% plus at least 10% weight loss (48.0% vs 21.0% of patients).
- Lilly's US Phase 2 tested higher doses: 18.1% weight loss at 32 weeks on 16 mg, with 20% stopping for side effects at that dose.
- There is no legal way for US patients to buy mazdutide. Online "mazdutide" is unapproved and unregulated.
What mazdutide is
Mazdutide is a Lilly molecule that Innovent Biologics licensed for China in 2019. Fierce Pharma reports that Lilly kept the rights everywhere outside China.
It belongs to the same broad family as survodutide and pemvidutide: drugs that pair GLP-1 with glucagon receptor activation. The glucagon side is thought to raise energy expenditure and pull fat out of the liver. That is why the liver-fat numbers in the trials below are worth paying attention to.
Innovent markets it in China as Xinermei. At launch, the company's recommended price for its highest approved dose was 2,920 yuan for four 6 mg pens, about $411 at the time, according to Reuters (via Zawya). Reuters noted it was the third once-weekly weight-loss injectable in China, after Wegovy and Mounjaro.
The approvals in China
Weight management (June 2025). Innovent announced the approval on June 27, 2025. The label covers adults with a BMI of 28 or higher, or 24 or higher with a weight-related condition such as high blood sugar, high blood pressure, abnormal lipids, fatty liver or sleep apnea (Innovent press release). Those cutoffs are lower than US cutoffs because China uses its own BMI definitions of overweight and obesity.
Type 2 diabetes (September 2025). Innovent announced the second approval on September 19, 2025, both alone and on top of metformin, sulfonylureas or SGLT2 inhibitors (Innovent press release).
Higher 9 mg dose. After GLORY-2, Innovent said China's NMPA accepted a supplementary application for 9 mg in people with moderate to severe obesity (Bariatric News). We did not find an approval decision for 9 mg in the sources we reviewed.
The GLORY obesity trials
| Trial | Dose and length | Mean weight change | Placebo | Notable secondary results |
|---|---|---|---|---|
| GLORY-1 | 4 mg, 48 weeks | −12.0% | −0.5% | 37.0% lost at least 15% |
| GLORY-1 | 6 mg, 48 weeks | −14.8% | −0.5% | 50.6% lost at least 15%; liver fat down 80.24% in those with high baseline liver fat |
| GLORY-2 | 9 mg, 60 weeks (BMI 30+) | −18.55% (−20.08% without diabetes) | −3.02% | 44.0% lost at least 20%; liver fat down 71.9% |
Sources: Innovent (GLORY-1, efficacy estimand); Patient Care and Clinical Trials Arena (GLORY-2).
GLORY-1 was published in The New England Journal of Medicine, per Innovent. GLORY-2 enrolled 462 adults with a mean starting weight of 94.0 kg, and 16% had type 2 diabetes. Discontinuation for side effects in GLORY-2 was 2.9% on mazdutide versus 0% on placebo, and GI effects were described as mild to moderate and transient (Patient Care).
One caution: these are Chinese populations with lower average body weight than most US trials. Percent weight loss travels better across populations than kilograms do, but head-to-head comparisons with US trials of other drugs are still not apples to apples.
Mazdutide isn't sold in the US
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The DREAMS diabetes trials, including two semaglutide matchups
The diabetes program is where mazdutide has faced established drugs directly.
| Trial | Comparator | HbA1c change | Weight change |
|---|---|---|---|
| DREAMS-1 (24 wk) | Placebo | −1.57% (4 mg), −2.15% (6 mg) vs −0.14% | −5.61%, −7.81% vs −1.26% |
| DREAMS-2 (28 wk) | Dulaglutide 1.5 mg | −1.69%, −1.73% vs −1.38% | −7.31%, −9.24% vs −2.86% |
| DREAMS-3 (32 wk, open-label) | Semaglutide 1 mg | −2.03% (6 mg) vs −1.84% | −10.29% vs −6.00% |
Sources: Innovent (DREAMS-1, DREAMS-2, efficacy estimand); Patient Care (DREAMS-3).
DREAMS-3 enrolled 349 Chinese adults with type 2 diabetes for less than 10 years and obesity. Its primary endpoint was the share of people who reached both HbA1c under 7% and at least 10% weight loss: 48.0% on mazdutide versus 21.0% on semaglutide (Patient Care). Two caveats matter. The trial was open-label, and the comparator was semaglutide 1 mg, the diabetes dose, not the 2.4 mg obesity dose.
A second head-to-head, GLORY-3, compares mazdutide 9 mg with semaglutide 2.4 mg in people with overweight or obesity and fatty liver disease. Innovent announced first dosing in that trial in May 2025 (Innovent press release). We did not find results as of October 2026.
Mazdutide's US status: what Lilly has actually done
This is the part most "mazdutide" articles get wrong. Here is what the record shows.
US Phase 2 in obesity
Lilly ran a 179-person, placebo-controlled Phase 2 at 24 US sites (NCT06124807), published online in The Lancet Diabetes & Endocrinology on August 21, 2026 (PubMed record of the Lancet paper). It tested much higher doses than China's approved label:
- 3 to 6 mg: −7.3% at week 32
- 10 mg: −15.6%
- 16 mg: −18.1%
- Placebo: −0.9%
Weight kept falling through week 48 at higher doses. The trade-off was tolerability: 20% of people on 16 mg stopped because of side effects, mostly GI. The authors noted that the 10 mg and 16 mg doses produced the largest reductions, which leaves the best long-term dose for later studies to settle.
Alcohol use disorder
Lilly also ran a 308-person Phase 2 proof-of-concept study of mazdutide in alcohol use disorder (NCT06817356). The registry lists it as completed, with the status updated in July 2026 (registry record). We did not find published results.
What hasn't happened
We found no FDA filing and no announced US Phase 3 obesity program for mazdutide in the sources we reviewed. Lilly already sells tirzepatide and is developing retatrutide, a triple agonist that also includes glucagon activity, so mazdutide's future outside China is genuinely uncertain. If Lilly does start Phase 3, approval would still be years away.
How to read mazdutide's numbers
Most of the headline figures above use the efficacy estimand, which assumes people stayed on the drug. Real-world results tend to be lower because some people stop. Innovent's releases emphasize the efficacy estimand, so look for the treatment-policy figures when full papers are published.
Dose matters too. China's approved doses (4 mg and 6 mg, with 9 mg under review) are lower than the 10 mg and 16 mg doses Lilly tested in the US, and the US trial showed tolerability getting harder as doses rose. If mazdutide ever reaches US patients, the label dose could look quite different from China's.
Questions worth raising with a prescriber if you're following this drug:
- Would a GLP-1/glucagon drug offer anything for my liver health that approved options don't?
- Am I a candidate for a clinical trial of a related agent?
- Which approved option best fits my diabetes status and side-effect history?
What's next for mazdutide in China
Innovent's approval release listed ongoing or planned work in adolescents, sleep apnea, MASH and heart failure with preserved ejection fraction (Innovent). Reuters reported that Morningstar estimated more than 600 million yuan in 2025 sales and peak sales of 3.5 billion yuan in 2029 (Reuters via Zawya). Those are analyst forecasts, not reported sales.
The bigger story is competition. Semaglutide's patent protection in China was set to expire in 2026, opening the door to domestic copies, per the same Reuters report. Mazdutide's case in China rests on the glucagon component: more liver fat reduction and, in DREAMS-3, better combined results than the 1 mg semaglutide dose.
Bottom line for US patients
Mazdutide is real, approved and selling in China, with solid Phase 3 data. For people in the US, it is a drug to follow, not one to seek out. If the GLP-1/glucagon approach interests you, the options are FDA-approved GLP-1 drugs now, or a clinical trial of a related agent. Talk to your prescriber about which fits your health history.
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Frequently asked questions
Is mazdutide approved in the US?
No. As of October 2026 mazdutide is approved only in China, where Innovent sells it as Xinermei. Lilly holds the rights outside China and published a US Phase 2 trial in August 2026, but we found no FDA filing or announced US Phase 3 obesity program.
How much weight do people lose on mazdutide?
In China's GLORY-1 trial, the 6 mg dose produced 14.8% average weight loss at 48 weeks versus 0.5% on placebo. In GLORY-2, the 9 mg dose produced 18.55% at 60 weeks versus 3.02%.
Is mazdutide better than semaglutide?
In the open-label DREAMS-3 diabetes trial, mazdutide 6 mg beat semaglutide 1 mg on reaching both HbA1c under 7% and at least 10% weight loss (48.0% vs 21.0%). That comparison used the diabetes dose of semaglutide, not the 2.4 mg obesity dose.
Can I legally buy mazdutide online in the US?
No. The FDA says a drug approved in another country but unapproved in the US is illegal to import, and products sold online as mazdutide are not the Innovent or Lilly product.
Sources
- Innovent: Mazdutide approved by China's NMPA for chronic weight management (June 2025)
- Innovent: Mazdutide approved for glycemic control in type 2 diabetes (September 2025)
- Fierce Pharma: With China approval, mazdutide breaks into new class
- Reuters via Zawya: Innovent's weight-loss drug highlights China challenge for Novo, Lilly
- Patient Care: Mazdutide 9 mg produces 20% weight loss in Phase 3 (GLORY-2)
- Clinical Trials Arena: Innovent boasts another pivotal trial success
- Patient Care: Mazdutide vs semaglutide head-to-head (DREAMS-3)
- Innovent: GLORY-3 first participant dosed
- Bariatric News: Innovent's mazdutide 9 mg accepted for review by China's NMPA
- PubMed: Hsia SH, Bays HE, et al. Mazdutide in US adults with obesity or overweight, phase 2 (Lancet Diabetes Endocrinol, 2026)
- Registry record: Mazdutide in alcohol use disorder (NCT06817356)
- FDA: Personal importation
- FDA: Concerns with unapproved GLP-1 drugs used for weight loss
Medical disclaimer: This article is general information, not medical advice, and does not replace a licensed clinician who knows your history. Approvals, labels, coverage and prices change; check the linked sources and talk with your prescriber or pharmacist before making decisions about any medication.